UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060309 |
|---|---|
| Receipt number | R000068988 |
| Scientific Title | A Randomized Open-Label Crossover Trial on the Effects of Pre-Meal Intake of Fermented Foods on Dietary Intake. |
| Date of disclosure of the study information | 2026/01/11 |
| Last modified on | 2026/01/09 11:37:33 |
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Basic information
Public title
A Randomized Open-Label Crossover Trial on the Effects of Pre-Meal Intake of Fermented Foods on Dietary Intake.
Acronym
A Randomized Open-Label Crossover Trial on the Effects of Pre-Meal Intake of Fermented Foods on Dietary Intake.
Scientific Title
A Randomized Open-Label Crossover Trial on the Effects of Pre-Meal Intake of Fermented Foods on Dietary Intake.
Scientific Title:Acronym
A Randomized Open-Label Crossover Trial on the Effects of Pre-Meal Intake of Fermented Foods on Dietary Intake.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of pre-meal intake of fermented foods on dietary content, satiety, and food preferences in healthy women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dietary Content (Nutrient Intake, Total Energy Intake, Energy-Producing Nutrient Balance, Intake by Food Group, Prescribed Meal Sequence).
Key secondary outcomes
Appetite (hunger, fullness, prospective food consumption, satiety), Preference, Well-being, Sleepiness.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Taking fermented food once before meals
Interventions/Control_2
Not taking fermented food before meals
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | > |
Gender
Female
Key inclusion criteria
(1)Women aged between 20 and 34 years old at the time of consent acquisition.
(2)BMI ranging from 18.5 kg/m2 to < 25 kg/m2.
(3)Persons who have been sufficiently informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate in the study based on a thorough understanding of the purpose and content of the study, and have given their consent to participate in the study in writing.
Key exclusion criteria
(1)Persons with a current or past medical history of severe liver dysfunction, kidney disease, cardiovascular disorders, respiratory disorders, endocrine disorders, metabolic disorders, digestive disorders, eating disorders, or taste disorders.
(2)Persons with digestive disorders affecting digestion and absorption, or a history of digestive tract surgery (excluding appendicitis).
(3)Persons regularly taking prescription drugs or quasi-drugs.
(4)Persons unable to discontinue consumption of health foods (including foods for specified health uses and foods with functional claims) or supplements during the trial period.
(5)Persons not consuming three regular meals per day.
(6)Persons with food allergies.
(7)Persons who habitually engage in severe selective eating or dietary restrictions.
(8)Persons who have difficulty consuming test foods and prescribed meals.
(9)Pregnant persons, persons planning to become pregnant during the trial period, and persons who are breastfeeding.
(10)Persons with irregular menstrual cycles.
(11)Persons with irregular work schedules, such as shift work or night work.
(12)Persons with a current or past history of drug dependence or alcohol dependence.
(13)Persons with a history of smoking.
(14)Persons who have participated in trials involving other drugs or foods within the past month, or who intend to participate in such trials.
(15)Persons deemed unsuitable as subjects by the principal investigator or sub-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0004
Address
Anera Bldg. 8F, 3-3-3 Higashi Nihonbashi, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Yokoshima |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO corporation
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joutou-machi,Maebashi-shi,Gumma
Tel
027-212-5608
sagawa@mc-connect.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 09 | Day |
Last modified on
| 2026 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068988
